Custom thermoplastic versus factory-made thumb orthoses for boutonniere deformity
Official title: Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
Run by Józef Piłsudski University of Physical Education · NCT06267469 · Data updated 2026-11-12
This test will see if a custom thermoplastic thumb orthosis helps women aged 18–65 with rheumatoid arthritis-related boutonniere deformity improve hand strength, dexterity, and pain compared with factory-made orthoses.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Józef Piłsudski University of Physical Education Academic / other |
| Locations | 2 sites (Warsaw, Masovian Voivodeship and 1 other locations) |
| Status | Recruiting |
| Started | July 6, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | September 3, 2025 |
| Trial ID | NCT06267469 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–65 with rheumatoid arthritis and a diagnosed type I or II boutonniere thumb deformity who consent and meet the required timing since surgery/injections are the intended participants.
✕Probably not a fit
Men, people with other thumb deformities, those less than one year after hand surgery, within six months of a thumb injection, or who change treatment during the study are excluded and unlikely to gain from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
About 60 participants (approximately 30 using custom thermoplastic orthoses and 30 using factory-made orthoses) will be enrolled to compare outcomes. Hand grip and pincer strength will be measured with a dynamometer, and dexterity and pain scores will be recorded with and without the orthosis at baseline and at scheduled follow-ups. The protocol focuses on female patients aged 18–65 with rheumatoid arthritis and type I or II boutonniere thumb deformity meeting the study timing restrictions for prior surgery and injections. The primary comparisons are change in dexterity, whole-hand and pincer grip strength, and pain between the two orthosis groups.
Why it matters
Potential benefit: If successful, the custom thermoplastic orthosis could improve grip and pinch strength, dexterity, and reduce pain more than factory-made orthoses.
How similar studies have gone: Custom thermoplastic splints are commonly used for hand deformities and small case series suggest benefit, but high-quality comparative data specific to rheumatoid boutonniere thumb deformity are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosed with RA * diagnosed thumb deformity: butonier finger, type I or II * female * age 18 - 65 years * patient's consent to the study Exclusion Criteria: * other deformity of the thumb * less than 1 year since surgical intervention in the hand * less than 6 months since delivery injections within the thumb * change in treatment during the study and 3 months before the study
Where it's running
-
Terapia Ręki Magda Kolasińska
Warsaw, Masovian Voivodeship, Poland Recruiting -
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, Masovian Voivodeship, Poland Recruiting
Study contacts
- Study coordinator: Magdalena Kolasińska, MSc
- Email: magdalena.kolasinska@awf.edu.pl
- Phone: +48609219822
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.